Every client is unique, every health tech product has its own characters, but some regulatory challenges are common during product development.
Learn how VCLS can provide you with tailored solutions to effectively move your product development forward.
Latest Case Studies
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Building an Efficient Path Towards Phase 2 Clinical Study in the US for a Live…
An APAC-based biotech had developed a live biotherapeutic product to target a rare liver disease with a high unmet medical…
Case study
Creating a complex IND whilst safeguarding confidential data between a CGT spin-off and CDMO
When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially…
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How to Optimize CMC for Successful Cultured Meat Product Development
Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore,…
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Innovative Marketing Authorization Transfer Preserves Vital Patient Supply
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
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How To Expedite Clinical Development Via Early Access Programs
If you are developing a drug for a rare disease in the European Union, you may qualify for an Early…
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A Proactive and Reactive Team in Orphan Drug Development
Are you in need of a proactive and reactive team in orphan drug development? An orphan drug is a designation…
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Key CMC Challenges for Innovative Healthcare Products
Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product…
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Early Asset Strategic Positioning Enhances Product Development Plan
A French based research company was looking for a proper guidance on positioning their main asset and estimate the market…
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